Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time to closure of the epithelial wound
研究概览
简要总结
CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies.
Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin.
The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Presence of keratoconus
- •Scheduled for corneal cross linking
- •No ophthalmic surgery in the 3 months preceding the study
排除标准
- •Participation in a clinical trial in the previous 3 weeks
- •Topical use of aminoglycosid antibiotics
- •Use of therapeutic or refractive contact lenses after surgery
- •Known hypersensitivity to any component of the study medication or heparinoids or heparin
- •Active ocular infection
- •Presence of any abnormalities preventing reliable measurements as judged by the investigator
- •Pregnancy, planned pregnancy or lactating
结局指标
主要结局
Time to closure of the epithelial wound
时间窗: 5 days
次要结局
未报告次要终点
研究者
Katarzyna J. Witkowska
MD, PhD
Medical University of Vienna